Head of Quality Assurance
4 weeks ago
Sun Pharma is seeking a highly experienced and skilled Head of Quality Control to lead our quality control operations and ensure the highest standards of quality in our drug products.
Key Responsibilities:- Develop and implement quality control strategies to ensure compliance with regulatory requirements and GMP norms.
- Manage the quality control team and resources to ensure smooth operation of the QC function, including release of incoming materials and drug products.
- Ensure analytical methods are validated and transferred to the site laboratory as per cGMP requirements and regulatory commitments.
- Monitor and review investigations and QMS with adequate CAPA to minimize errors.
- Design, implement, and review quality systems and procedures to ensure compliance with regulatory requirements and company policies.
- Facilitate harmonization and consistent implementation of quality systems and procedures at site, in alignment with regional and global quality policies and standards.
- Assure all-time readiness of site for regulatory agency inspections and internal audits, and implement corrective actions regarding observations made by the agencies and internal audit teams.
- Provide strong leadership and expertise to ensure achievement of all Quality Control accountabilities at site.
- Coach and develop direct and indirect reports through ongoing performance feedback, annual performance reviews, and training and development opportunities.
- Ensure performance issues are managed in a consistent and timely manner.
- Develop site quality control revenue and capital budgets and headcount projections, track and manage expenditures and headcount to budget over the fiscal year.
- Ensure compliance to regulatory requirements on product, process, and release procedures.
- Ensure smooth collaboration with all Sun Pharma sites and leverage synergies.
Requirements:
Science or Pharmacy Graduates or Equivalent
18+ years of experience (with USFDA & OSD background)
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